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Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Zhen Zhang, Fudan University.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 24, 2012
Last Update Posted: August 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhen Zhang, Fudan University
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.

Condition Intervention
Rectal Cancer Radiation: radiation therapy Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Zhen Zhang, Fudan University:

Primary Outcome Measures:
  • circulating tumor cells level changes after radiotherapy [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ]
  • disease-free survival [ Time Frame: 3 years ]
  • serum carcinoembryonic antigen (CEA) level [ Time Frame: 3 years ]
  • pathological response (tumor regression grade)if surgery [ Time Frame: 3 years ]
  • RECIST-based tumor response at 10 week after radiotherapy [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
whole blood

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Groups/Cohorts Assigned Interventions
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
Radiation: radiation therapy
Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
Other Name: Xeloda


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
rectal cancer diagnosed with stage II-IV

Inclusion Criteria:

  • Histologically verified rectal carcinoma
  • Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
  • the distance from anal verge <= 12cm
  • with or without metastasis
  • Age 18-75 years old
  • ECOG PS 0-2
  • No previous chemotherapy or radiotherapy for rectal carcinoma
  • Written informed consent

Exclusion Criteria:

  • no histologically verified rectal carcinoma
  • rectal cancer with stage I
  • distance from verge >12cm
  • age <=18 or >=75 years old
  • performed previously chemotherapy or radiotherapy
  • infection diseases within three months
  • serious other diseases
  • no written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671891

Contact: Wenjie Sun, Master 86-21-64175590-1600 ganjumedecin@hotmail.com

Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Wenjie Sun, Master    86-21-64175590    ganjumedecin@hotmail.com   
Principal Investigator: Zhen Zhang, PhD,MD         
Sub-Investigator: Wenjie Sun, Master,MD         
Sponsors and Collaborators
Fudan University
  More Information

Additional Information:
Responsible Party: Zhen Zhang, director of radiotherapy department in Fudan university shanghai cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT01671891     History of Changes
Other Study ID Numbers: SCRC-NM-1001
First Submitted: July 19, 2012
First Posted: August 24, 2012
Last Update Posted: August 24, 2012
Last Verified: August 2012

Keywords provided by Zhen Zhang, Fudan University:
rectal cancer
circulating tumor cells
predict responses

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplastic Cells, Circulating
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents